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Project Manager, Oncology at Unum Therapeutics

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Project Manager, Oncology at Unum Therapeutics

Who are we?

Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies.We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

What are we offering to you?

This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

What will you be doing?

  • You will provide project management leadership for Unum’s lead clinical program.

  • You will provide team leadership through establishing and maintaining focus, direction and motivation of team members, creating an atmosphere of trust, leveraging diverse views, and encouraging innovative solutions.

  • You will develop comprehensive project plans and associated communications to coordinate, monitor, and track all project activities and schedules to ensure quality and timely completion.

  • You will integrate the scientific, clinical, and manufacturing teams’ contributions to all aspects of the program’s deliverables.

  • You will prepare and present written and verbal materials to define resource requirements, project workflow, and budgets.

  • You will provide leadership support as required for research and development alliances and partnerships.

  • You will interact with partners inside and outside of Unum on the various day-to-day needs and drive projects to decisions; attention to detail is critical.

  • You will provide routine reporting to management on program, and where appropriate, alliance activities, including financial and governance activities.

  • You will report to the Chief Medical Officer and be a valuable leader and contributor to other initiatives as they arise in our fast paced, startup environment.

Who are we seeking?

  • BA or BS with at least 5 years of industry experience, the majority of which resides in project and/or alliance management, is mandatory; direct experience in early development asset teams in either oncology or immunology is required, along with mastery of all relevant project management tools.

  • Relevant advanced degree, e.g. PhD, MBA, or M.Sc., and/or certification in project management is preferred.

  • Significant experience developing effective partner relationships and building strong working alliances with internal teams and leadership

  • Proven experience in building and maintaining high performing teams

  • Experience in the biopharmaceutical industry with understanding of the pharmaceutical industry and the development, manufacturing and commercialization of new drugs, having worked in an emerging and commercial stage company is preferred

  • Expertise in contemporary project and alliance management practices and metrics

Where are we?

Unum is located in a new facility located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building.  We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners.  This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What benefits does Unum offer?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), trust-based time-off, a 401(k) plan,and commuter/parking benefits.

How to Apply?

Please send cover letter and resume to: careers@unumrx.com

Unum is an equal opportunity employer.

We are only accepting applications from candidates with authorization to work in the United States at this time.

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

 


Head of Development Operations, at Unum Therapeutics

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Head of Development Operations, at Unum Therapeutics

Who are we?

Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies.We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

What are we offering to you?

This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

What will you be doing?

  • You will be a critical, full, and active participant of the Development leadership team, reporting directly to the Chief Medical Officer

  • You will hold primary accountability for the design and implementation of the operational model for Development at Unum. This is anticipated to include Clinical Operations, Data Management and Standards, Trial Costing and Analytics, Clinical Supply, Training and Compliance, and Quality Assurance

  • While firmly adhering to GCP and quality standards, you will build a team suited for the evolving business needs and scale of the portfolio while optimizing timelines and costs

  • You will take primary responsibility in building the critical operational interfaces with the Unum Discovery and Manufacturing teams, and together shape key strategic decisions across the Unum portfolio

  • You will share accountability to proactively identify, communicate and manage development risks with senior management

  • You will be responsible for building and maintaining key vendor and partner relationships

  • You will work in partnership with Finance to provide the key assumptions, and business processes, to support all Development cost forecasting, budgeting, and tracking

  • You will support business development and partnering activities through leadership in due diligence, provide input in forecasting and modeling, and skills presentations to potential partners

  • You will be responsible for creating and leading a motivated, high performing team regardless of their position as Unum employee, consultant or as a professional colleague within our vendor structure

  • You will travel relatively infrequently (approximately 10-15% of your time)

  • You will contribute to the creation of a “can do”, innovative culture and be a valuable leader and contributor to other initiatives as they arise in our fast paced, start-up environment

Who are we seeking?

  • An independent, flexible, high-energy expert in development operations, with a high level of clinical and business acumen and results-proven track record of exceeding goals

  • At least a BA or BS or equivalent, with preferably an advanced degree (e.g. MBA, PhD, or Master’s), at least 15 years of relevant work experience, of which at least 7 years includes direct supervisory experience; a science degree is preferable but not required

  • Sufficient mastery of oncology, oncology drug development, and clinical research principles as well as a thorough understanding of the drug development process, the regulatory process, and relevant interfaces with manufacturing.

  • Prior CRO or Biopharma experience with >1 operating model within a development organization of moderate to large scale is necessary

  • Extensive experience with compliance issues and strong understanding of FDA regulations; EU Clinical Trials Directive, GCP and/ SOPs in pharmaceutical, or biotech environment is a requirement

  • Excellent interpersonal, leadership and self-direction skills; good judgment in handling difficult situations, conflict resolution skills and good organizational, time management skills; strong verbal and written communication skills

  • Demonstrated success in a prior leadership positions and proven ability to effectively build organization and staff capacity, developing a top-notch workforce and the processes that ensure the organization runs smoothly

  • Previous experience directly contributing to the overall strategic direction of the company or business unit within your sphere of expertise is strongly desired

  • Working knowledge of GCP guidelines, ICH regulations, and all other applicable regulatory rules and guidelines

  • Previous direct experience in alliance and/or vendor/strategic partner management is strongly desired

  • Should have a bottom-line orientation; evidence of the ability to consistently make good decisions through a combination of analysis, wisdom, experience, and judgment

  • A demonstrated track record of balancing the delivery of programs against the realities of a budget

Where are we?

Unum is located in a new facility located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building.  We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners.  This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What benefits does Unum offer?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), trust-based time-off, a 401(k) plan,and commuter/parking benefits.

How to Apply?

Please send cover letter and resume to: careers@unumrx.com

Unum is an equal opportunity employer.

We are only accepting applications from candidates with authorization to work in the United States at this time.

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

Environmental Health & Safety Specialist

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Whitehead Institute for Biomedical Research is a leading, nonprofit research and educational institution that has defined the cutting edge of biomedical science, creating a legacy of research excellence and academic eminence since 1982.​ Wholly independent in its governance, finances and research programs, Whitehead shares a teaching affiliation with Massachusetts Institute of Technology (MIT), offering the intellectual, collegial and scientific benefits of a leading research university.​ Whitehead’s Faculty Members and Fellows run pioneering programs in cancer research, immunology, developmental biology, stem cell research, regenerative medicine, genetics and genomics—programs with a record of success.​

 

Director David C.​ Page likens the Institute to an artists’ colony.​ “What we do here at Whitehead is attract the best possible intellectual capital and empower maximally creative—really wildly creative—individuals to realize their dreams within these walls”.​

 

CLASSIFICATION:             Exempt; Administrative Staff

REPORTS TO:                      Associate Director of Environmental Health & Safety

 

OVERALL RESPONSIBILITY

 

Provide primary support for the Environmental Health & Safety programs at the Whitehead Institute. This person will be responsible for identifying and implementing EH&S strategies which apply to industrial hygiene, safety and chemical regulatory requirements, emissions-waste-water management, including all applicable permitting and reporting requirements. Engage directly with lab scientist to ensure compliance with Federal, State and local regulatory requirements for biomedical laboratory operations.

 

We are looking for a candidate who thrives in an interdisciplinary environment, is an excellent communicator and is self-motivated.

 

CHARACTERISTIC DUTIES

 

  • Review appropriate government (Federal, State and City of Cambridge) regulations, determine the applicability to the Institute, and update or write policies and procedures in practical ways to be delivered to the different user groups.
  • Audit policies and procedures to ensure understanding, compliance, and user comprehension. Procedures include, but are not limited to; Regulated Waste, New Chemical Review, Hazardous Communication, Incident Investigation, SPCC, RCRA and Tier II Reporting, MWRA, Industrial Hygiene, Ergonomics, IATA Shipping and Process Safety Management.
  • Oversee the chemical hygiene program and the chemical waste program, the later primarily staffed by contracted vendors.
  • Perform/oversee lab and satellite accumulation area inspections.
  • Review chemical orders and manage chemical inventory system.
  • Coordinate annual chemical fume hood certification and repair program, in conjunction with MIT’s IH group. Maintain records of certification.
  • Provide guidance on the process for researchers seeking to use MA DPH or DEA Controlled Substances.
  • Prepare environmental summaries, training reports, regulatory summaries, filings and reporting requirements.
  • Regulatory Reports:
    • Chemical Hygiene Plan
    • Universal Waste Plan
    • DOT Security Plan
    • SARA Title III Tier 2 Report / LEPC filings
    • Air Monitoring and Emissions Reporting
    • MWRA yearly reporting
    • DHS Chemicals of Concern Oversight
  • Coordinate Lab Decommissioning.
  • Assist with the Radiation Safety Program, as needed.
  • Identify, implement and manage third party service providers for EH&S services.
  • Share emergency response responsibilities with other EH&S staff members (24 hour call, seven days a week).  This includes decisions on building closure, interface with municipal and contractor emergency responders via the Incident Command System.
  • Attend training classes, as needed, to maintain certifications to perform job in compliance with regulatory requirements, e.g. Incident Command, Haz Mat, DOT, IATA etc.
  • Serve in the 24 hour on-call service rotation. 
  • Perform other special projects, as required.

 

QUALIFICATIONS

 

Education

 

  • Bachelor’s degree in Environmental Health and Safety, Chemistry or Science.            

 

Experience

 

  • Minimum of five to eight years related experience in a research laboratory environment. Background in Industrial Hygiene and current DOT and HMM certification preferred.
  • Experience in emergency situations; 40 hour HAZWOPER training a plus.
  • Certified Industrial Hygienist CIH preferred.
  • Previous security clearance a plus.
  • Ability to prioritize and work well both independently and as a team member.
  • Strong interpersonal, verbal and written communication skills.
  • Proficient in the use of computers and applications.

 

Interested candidates should send resume to:

 

resumes@wi.mit.edu

Whitehead Institute for Biomedical Research

9 Cambridge Center

Cambridge, MA 02142

Software Engineer (Production Quality)

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Ultivue is an early stage life science tools company based in Cambridge, MA.  We are looking for a software engineer to join our team to help develop transformative technologies in biological imaging applications.  You will create software that has the potential to reach thousands of laboratories around the world.  As a software engineer at Ultivue, you will work together with scientists to develop a cohesive hardware and software platform that will allow researchers and clinicians to see the molecular world with unprecedented clarity.  Your efforts will drive new capabilities in molecular technology leading to advanced research opportunities, diagnostics, drug discovery, and much more.

Job description

You will build the first release-ready version of the software based on our previously developed prototypes and algorithms.  You will create a robust software package with intuitive graphic user interface for both Mac and PC users.  Cloud-based software is an option.  Later on, you will lead the implementation of additional algorithms and features for advanced versions.  You will be responsible for all aspects of the software including the architecture, algorithm implementation, memory management, GUI layout and system compatibility.  You will also be expected to confer with alpha and beta testers as well as customers to make steady improvements on the usability and utility of the software.

Required qualifications

- BS or higher and cumulative 4+ years experience in Computer Science or related field.

- Strong programming skills with object-oriented languages (C++, Java).

- Advanced MATLAB programming.

- Aptitude and passion for learning new programming languages, technologies, and algorithms.

- 2+ years experience in production-quality software development.

- Significant background in large-scale image processing applications.

- Training and experience in designing and implementing UIs for standalone software (PC/Mac).

- Strong technical learning and communication skills, especially with non-engineers.

- Comfortable working independently and tackling large projects.

Preferred qualifications

- MS or higher in science or engineering field.

- Experience with writing ImageJ plugins

- Experience with server management, arduino, instrumentation hardware.

- Familiarity with chemical and biological sciences.

Interested? Please send cover letter and resume to contact@ultivue.com

 

PKPS SAS Programmer

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Position Summary:

The primary objectives of this position are to assist the clinical pharmacology group in the preparation data sets for pharmacokinetic and pharmacodynamic analyses using SAS. The incumbent will prepare data sets for population pharmacokinetic analyses for NONMEM, CDISC datasets (PC, PP) and prepare TFLs. The incumbent will also perform exploratory data and statistical analyses and will develop SAS macros on an as needed basis. Clear and concise documentation of the generated SAS code is expected.

Duties and Responsibilities:

1. Prepare data sets from multiple sources for pharmacokinetics /pharmacodynamics, dose-response and exposure-response relationships analyses.
2. Implement standard programming for data pre-processing and data post-processing (NONMEM data file, CDISC datasets or table listing and analysis report for PK/PD studies) in a quality controlled and validated environment by using SAS.

3. Provide assistance in drafting clinical study reports and modeling reports with tables, listings and graphs.

4. Work with clinical pharmacokinetic and pharmacometric scientists to perform exploratory, and statistical analyses as needed basis.

5. Develop global SAS macros to improve efficiency of pharmacokinetic and pharmacodynamic analyses

6. Validate pharmacokinetic and pharmacodynamic data sets/analyses and document data set validation according to company SOP's

Requirements
Education and Prior Experience
MS degree in pharmaceutical sciences or statistics, with at least 3 years of experience in creating CDISC and NONMEM datasets is required. Strong SAS, macro and R programming skills. A working knowledge of S-plus, Sigma Plot or equivalent graphics software, and Phoenix WinNonlin (or equivalent) is desired.
Additional Comments
The selected individual must be a self-starter, highly motivated and innovative. It is also expected that the individual will be able to work closely with staff scientists and require a modest level of supervision. Excellent inter-personal skills are required since these individuals will be working with scientists from different disciplines. Customer driven focus is a must.

Research Associate

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Major Responsibilities

  • Under direction of the  team Technical Lead, the Research Associate will prepare and conduct laboratory studies in support of the development and implementation of Immunohistochemistry (IHC) and In Situ Hybridization ISH) In Vitro Diagnostic assays.
  • Working independently on routine laboratory work and managing instructions on new assignments.
  • Supporting the Technical Lead and associated project teams to ensure technical and statistical concerns related to diagnostic assay design are evaluated with results communicated where and as appropriate.
  • Ensure all work is conducted in accordance with applicable requirements, including Design Controls, protocols, work instructions, lab notebook requirements, etc.
  • Communicate and collaborate effectively at all times within the R & D team.
  • Support and actively engage in culture of continuous process improvement.
  • Work closely with Program Managers to ensure they are performing required tasks in a timely manner in support of project planning through appropriate scheduling of work and communication of status of assigned tasks.

 

Required Skills/Experience

  • At least 2 +Years industry experience preferably gained within an IVD development environment.
  • Awareness of requirements and experience of working competently within a regulated environment in which diagnostic assays are developed, commercialized and supported (i.e.   FDA QSR, ISO 13485, etc.) 

Senior Director, Regulatory Affairs and Quality Assurance

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Jounce Therapeutics is taking a broad approach to one of the most exciting fields in cancer therapy today.  Based in Cambridge, MA, we are developing protein-based therapeutics aimed at achieving durable anti-tumor immune responses for multiple cancer indications. Leadership includes an experienced management team, in concert with world-class advisors in the field of cancer immunotherapy.  As a company at the forefront of cancer immunotherapy, we are seeking highly motivated, hard-working, creative, and collaborative individuals.

 

Sr. Director, Regulatory Affairs and Quality Assurance

 

 

Job Description

 

Primary Duties:

The Senior Director of Regulatory Affairs and Quality Assurance is responsible for developing and directing the global regulatory strategy, objectives, policies and programs from IND through NDA or BLA and commercialization, and for implementing, maintaining, and overseeing audit ready quality systems.  As the company grows, the Sr. Director will build and lead a team of regulatory and quality professionals to meet development and commercial needs.

Responsibilities:

  • Accountable for design and implementation of regulatory strategies for all products from IND through BLA or NDA and commercialization.   
  • Initially functions as the global regulatory lead for all projects, working with cross-functional teams to drive and implement global regulatory strategies.  As the company grows, oversees a team of global regulatory leads and junior staff and ensures alignment between regulatory team representatives and senior management.
  • Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for all projects.
  • Leads the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs, applications for Orphan Drug status, Fast Track, and Breakthrough Therapy designations and other relevant regulatory filings.
  • Primary corporate contact with regulatory Health Authority (HA) agencies and effectively leads key meetings with HAs to ensure full discussion of issues and opportunities.
  • Company expert on current regulations and guidance, interprets and notifies appropriate personnel; provides guidance to all appropriate departments to assure compliance with applicable regulations. 
  • Provides regulatory input on competitive intelligence, including notification and education of personnel about all relevant new regulatory approvals.
  • Oversees development, implementation, and maintenance of quality systems to ensure audit readiness appropriate for each stage of development.
  • Oversees creation, implementation, training, and maintenance of training for all company personnel on Standard Operating Procedures.
  • Trains and mentors junior staff.

 

Education and Experience Requirements:


  • BS, BSc, MS, MSc, PhD, or PharmD, in science or healthcare preferred or equivalent relevant experience. 
  • At least 10 years Regulatory Affairs experience in biologics, with IND through BLA both US and ex-US. Experience in immuno-oncology preferred.
  • Knowledge of regulations concerning companion diagnostics; personal experience preferred.
  • Familiarity with Regulatory CMC for monoclonal antibodies
  • 5 plus years of management experience preferred

 

Other Job Requirements

  • Enthusiastic, passionate about bringing important new therapies to patients with cancer, and willing to roll up his or her sleeves to do whatever it takes while building the right team of outstanding regulatory and quality professionals.

 

To be considered for this role, please submit your resume to Careers@JounceTx.com with the job title in the subject line of your email.

We are an equal opportunity employer offering a competitive salary and benefits package.

All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not responsible for any fees related to resumes that are unsolicited

 

 

Research Associate: Companion Diagnostics

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Position Summary and Overview

This role is responsible for the undertaking of research and development activities to support the attainment of business goals.  It will be responsible for undertaking relevant work, making observations, reporting data and providing results to support key decisions within the Companion Diagnostics group.  A proven ability to communicate and work with all levels of staff and external collaborators is fundamental to this role.

 

Major Responsibilities

  • Under direction of the  team Technical Lead, the Research Associate will prepare and conduct laboratory studies in support of the development and implementation of Immunohistochemistry (IHC) and In Situ Hybridization ISH) In Vitro Diagnostic assays.
  • Working independently on routine laboratory work and managing instructions on new assignments.
  • Supporting the Technical Lead and associated project teams to ensure technical and statistical concerns related to diagnostic assay design are evaluated with results communicated where and as appropriate.
  • Ensure all work is conducted in accordance with applicable requirements, including Design Controls, protocols, work instructions, lab notebook requirements, etc.
  • Communicate and collaborate effectively at all times within the R & D team.
  • Support and actively engage in culture of continuous process improvement.
  • Work closely with Program Managers to ensure they are performing required tasks in a timely manner in support of project planning through appropriate scheduling of work and communication of status of assigned tasks.

 

Required Skills/Experience

  • At least 2 +Years industry experience preferably gained within an IVD development environment.
  • Awareness of requirements and experience of working competently within a regulated environment in which diagnostic assays are developed, commercialized and supported (i.e.   FDA QSR, ISO 13485, etc.) 
  • Technical expertise in IHC and ISH assays preferably on automated staining platforms
  • Excellent communication skills with an ability to evaluate and concisely articulate complex scientific and business issues and contribute to the implementation of solutions. 

 

Competencies

  • Excellent communication skills – written and verbal 
  • Ability to perform in a dynamic, highly collaborative environment is essential
  • An ability to exercise sound judgement within defined practices and techniques.
  • An ability to handle multiple tasks and manage priorities accordingly
  • High levels of initiative, self-motivation and energy.

 

Education List of Education, Certifications, Training

  • BSc in a Scientific discipline

Lentiviral Process Characterization Scientist

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Unique role here at an A level research group in Cambridge, MA for someone with good cell culture skills and a strong work ethic.

Requirements:

  • BS/MS in biochemistry or related field with 2-7 years experience in drug discovery
  • Strong cell culture skills with the ability to perform high throughput assays and good attention to detail
  • Adept at qPCR and ELISA to analyze in process and final lentiviral vector samples used in many stages of research
  • Experience managing assays/workstreams that have been outsourced to a CRO/CTO is a plus

About StratAcuity

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Manager/Sr. Manager, EHS & Facilities

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Infinity’s Operations group is seeking a team member to concentrate on Facilities and Environment Health & Safety needs and assist in leading the Facilities team in support of the company’s drug discovery and development efforts. The ideal candidate has previous experience in facilities management in biotechnology and should be familiar with regulations pertaining to occupational health/safety and environmental issues especially hazardous waste regulations. Good communication and organizational skills are also required. Exact title and compensation will be commensurate with education and experience. Flexible schedule required.
 
Responsibilities:
  • Assist the Director, Facilities Operations in managing the Facilities team
  • Help manage building management system, security system, cleaning program and other facilities programs
  • Manage the development, planning and implementation of laboratory safety programs within the company
  • Ensure compliance with all state, federal and local governmental EH&S regulations; Includes written programs, record keeping, reports, inspections, monitoring, testing, training and medical surveillance per guidelines, serves as liaison with government regulatory agencies
  • Oversee existing EHS and ergonomic programs; act as the primary contact for onsite hazardous waste , biological waste, and radioactive waste vendors
  • Serves an internal consultant on ergonomics, hazardous materials, chemical hygiene, and chemical safety matters
  • Ensure all required permits and licenses are in place
  • Oversee shipping of dangerous goods and regulated material by IATA and DOT
  • Work as an integral member of the operations team, providing support as needed
  • Assist with coordinating building and infrastructure maintenance, including planned maintenance, unplanned/emergency maintenance and prosecution of routine work orders
  • Participate as an active member in the company’s Crisis Management and business continuity program, including responsibility to act as Incident Commander during any crisis situation
  • Direct internal resources associated with people/equipment moves/adds and changes
Requirements
  • BS Degree in Science, Facilities operations, EHS or equivalent, 8 – 12  years relevant experience working in facilities operations and/or EHS
  • Understanding of building systems, including HVAC, electrical and plumbing systems
  • Demonstrated awareness and implementation of biotechnology/pharmaceutical industry laboratory safety practices
  • Facilities experience in the area of life science, and/or scientific research is required
  • Experience and exposure to capital improvement and related projects is preferred
  • Current knowledge of emerging trends in industrial/laboratory safety
  • Excellent working knowledge of state and federal industrial standards and practices such as: RCRA, OSHA, DOT and IATA, HAZWOPER required; CHMM preferred
  • Understanding of the hierarchy, structure and processes of appropriate regulatory agencies
  • Excellent verbal and written communication skills
  • Ability to work well in a fast-paced, multi-disciplinary team environment
  • Must be proactive and self-motivated
  • Attention to detail is critical in this role as is the ability to think on one’s feet and respond accordingly
  • An early first shift start or 7:00/7:30 am start ideal
  • Previous experience working within a structured, facilities helpdesk is preferred
  • Previous vivarium experience preferred

To apply, please visit our website at http://www.infi.com

Sr. Engineer – Process Engineering, Clinical & Commercial Drug Substance

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Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

We are seeking a:

Sr. Engineer – Process Engineering, Clinical & Commercial Drug Substance  

(Position located in Thousand Oaks, CA)

The successful candidate will apply process engineering knowledge and leadership skills in support of clinical and commercial drug substance manufacturing at Amgen’s Thousand Oaks site.

This individual will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production. Scope includes: manufacturing and regulatory support for both mammalian and microbial processes; lead data trending and advanced statistical & process analysis; provide technical support for all process related NCs, CAPAs and change controls; provide technical support for new equipment, technology and capital projects in the facility; identify and support process related operational excellence opportunities; manage Process Validation activities occurring at the site; Presentation of process performance at team and management meetings; Process modeling to guide process development activities, identify process implementation issues and drive optimization; Technical project management; Support of regulatory filings and inspections.

Basic Qualifications:

Doctorate Degree OR Master's Degree & 3 years of Engineering experience OR Bachelor's Degree & 5 years of Engineering experience

Preferred Qualifications:

BS Chemical/Biochemical Engineer or other biological engineering discipline and 8 years Process Engineering experience supporting GMP manufacturing;
Downstream process knowledge and hands on pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance.
Process characterization, process validation and process monitoring experience
Good written and verbal communication skills
Experience in preparing regulatory filings and participation in regulatory inspections
Process development and optimization experience with late stage or commercial products
Process equipment design and evaluation expertise
Experience with risk analysis methodologies
Understanding of biologics commercialization and regulatory approval process
Proven track record of successful leadership and collaboration
Excellent organizational, leadership, teamwork, and communication skills are required as well as the ability to work effectively in a dynamic and challenging environment with enthusiasm and a proactive positive attitude.

 Interested candidates, please email resume to smaguire@amgen.com

Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

 

 

 

Sr. Engineer – Digital Integration and Predictive Technologies

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Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

We are seeking a:

Sr. Engineer – Digital Integration and Predictive Technologies

(Position located in Cambridge, MA)

Amgen’s Digital Integration and Predictive Technologies organization is a global process development function that develops and deploys state of the art advanced computational technologies in: 1) data capture, integration and management, 2) empirical and first principles modeling towards improved process understanding and robustness, and 3) monitoring, prediction and optimization of manufacturing. We are seeking a Senior Engineer to provide hands-on technical support, analyses, and assessments for a broad base of clients globally by leveraging expertise in process analytics, computational and multivariate modeling for production of bio-therapeutics. The Senior Engineer will address a wide variety of challenging problems across many organizations including: drug substance, drug product and drug delivery devices. Responsibilities will include designing and running bench-scale experiments for model-based control studies, preparation of internally reviewed technical reports as well as participation in and presentation of results at department and project meetings. Use of developed models and their underlying technical basis will be deployed and taught to the broader engineering and scientist community responsible for delivering processes to operations

Basic Qualifications:

Doctorate Degree OR Master's Degree & 3 years of Engineering experience OR Bachelor's Degree & 5 years of Engineering experience

Preferred Qualifications:

Ph.D. with experience noted in the basic qualifications above.
5+ years relevant work experience in bio/pharmaceutical applications.
Experience in process development and/or Computational Modeling and Control techniques
Experience with biopharmaceuticals processes, related unit operations.
Solid understanding of biochemical engineering, metabolic flux models and closed-loop control.
Hands-on bench or pilot-lab experience to work with experimentalists to generate data for model building and validation
Excellent programming skills in any of the following: C++, Perl, Java, C# , Matlab, Python, R
Basic understanding of laboratory automation and information systems such as Delta V, OPC and PI.
Knowledge of current state of the art technologies and emerging scientific and regulatory directions for process control towards minimizing and controlling process variability as well as new technologies to improve control, information and knowledge management in process lifecycle.
Strong interdisciplinary project management skills.
Ability to independently uncover and resolve issues associated with the development and implementation of scientific and engineering projects.
Should be recognized in the scientific and engineering community through a sustained record of publications and/or patents.
Understanding of bulk protein process and formulation/finish unit operations including analytical methods and process controls.

 Interested candidates, please email resume to smaguire@amgen.com

Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

 

 

 

Scientist: Companion Diagnostics

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Position Summary and Overview

This role is responsible for the management of research and development activities which will drive the achievement of business goals / partner expectations.  The role will be responsible for planning and undertaking relevant work and using professional judgement to drive key decisions within the Companion Diagnostics group.  A proven ability to communicate and work with all levels of staff and external collaborators is fundamental to this role.

 

Major Responsibilities

  • Under the guidance of the  team Technical Lead, the Scientist will plan, manage and report out on laboratory studies in support of the development and implementation of Immunohistochemistry (IHC) and In Situ Hybridization ISH) In Vitro Diagnostic assays.
  • Working with a high degree of autonomy to ensure key milestones are met.
  • Supporting the Technical Lead and associated project teams to ensure technical and statistical concerns related to diagnostic assay design are evaluated with results communicated and action plans initiated where appropriate.
  • Ensure all work is conducted in accordance with applicable requirements, including Design Controls, protocols, work instructions, lab notebook requirements, etc.
  • Communicate and collaborate effectively at all times within the R & D team.
  • Support and actively engage in culture of continuous process improvement.
  • Work closely with Program Managers to ensure they are performing required tasks in a timely manner in support of project planning through appropriate scheduling of work and communication of status of assigned tasks.

 

Required Skills/Experience

  • At least 5 +Years industry experience preferably gained within an IVD development environment.
  • Sound and demonstrable awareness of the relative requirements of and proven experience of working competently within a regulated environment in which diagnostic assays are developed, commercialized and supported (i.e.   FDA QSR, ISO 13485, etc.) 
  • Demonstrable technical expertise in IHC and ISH assays preferably on automated staining platforms
  • Excellent communication skills with an ability to evaluate and concisely articulate complex scientific and business issues and contribute to the implementation of solutions. 

 

Competencies

  • Ability to perform in a dynamic, highly collaborative environment is essential
  • An ability to drive for results effectively whilst proactively managing resource and timelines.
  • An ability to exercise sound judgement within defined practices and techniques.
  • An ability to handle multiple tasks and manage priorities accordingly
  • High levels of initiative, self-motivation and energy.

 

Education List of Education, Certifications, Training

  • BSc in a Scientific discipline
  • MSc in a relevant field would be desirable

Research Data Specialist - Biostats

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Job ID: 27095
Date Posted: 09/16/2015
Location: Center for Life Sciences
Job Family: Clinical Research
Full/Part Time: Full-Time
Regular/Temporary: Regular
About Dana-Farber

Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.


Overview

The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

Our Core Values are:

Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

Compassion and respect - For those in our care and for one another.

Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.

 

The Research Data Specialist will support the Multiple Myeloma clinical research program in the areas of data collection, computing, and database organization. Duties include the examination, synthesis, and evaluation of medical records; the abstraction and recording of pertinent medical information. Also included are evaluating and tracking the eligibility of all patients seen in the clinic for inclusion in the database. The Clinical Data Specialist will be responsible for the collection, management, and quality assurance review of patient clinical data.

The specialist will maintain on-going communications with staff (internal and external) for data collection needs. Works as part of a research team to create and utilize a large database of clinical information and biological specimens. Understands basic principles of human research subject protection.

Duties & Responsibilities

• Identification of patients to be entered to the database.

• Reviewing and abstracting the medical records for patient data and the monitoring of patient status over time.

• Responsible for maintaining long-term outcomes data and locating past patients who are long-term cancer survivors.

• Reviewing data for quality and completeness and assisting with QI/QA of the database.

• Generating reports from the database.

• Collaborate with the Multiple Myeloma program in the continued development of data capture forms.

• Supervise others in the data collection

Qualifications:

• Bachelor’s Degree required with 2 years of related experience preferred.

• Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

• Excellent organization and communications skills required.

• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.

• Must be detail oriented and have the ability to follow-through.

• Ability to effectively manage time and prioritize workload.

• Must have computer skills including the use of Microsoft Office.

Supervisory responsibilities:

• Supervise others in the data collection



Schedule

M-F, 9-5:30



How to Apply

Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.



Equal Employment Opportunity

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

 

Apply Here

PI92341076

Senior Scientist, R&D Imaging

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Position Overview and Responsibilities:

As the Senior Scientist, R&D Imaging you will help to craft and articulate the overall Decibel Imaging strategy.  Your initial focus at Decibel will be to determine the requirements for inner ear imaging platforms and develop approaches suitable to both specific high priority projects as well as potential long-term platforms. You will lead the effort to develop a hierarchy of techniques, equipment, and imaging standard operating protocols as well as establish potential academic collaborators and business partners. Leading the set-up, validation, and continuing improvements of day to day work-horse histopathologic techniques you will also assume the responsibility for day to day histopathology: perfusions, sectioning, staining, data accumulation, interpretation and report writing. By regularly surveying the field for new developments, you will ensure that Decibel maintains it’s understanding of imaging options and related content at “state of art”. As one of the key early hires for the company, you will work in close collaboration with the management team and scientists to ensure that imaging options for our programs (pre-clinical and clinical) are based on solid scientific foundations, accurate feasibility assessments, and grounded in realistic, corporate aligned goals. 

Requirements: 

  • PhD in Hearing or Neuroscience with a minimum of 5 years experience in industry
  • Broad hands-on expertise in imaging approaches and histology techniques, including tissue and sample preparation and sectioning, immunohistochemistry, in situ hybridization, light microscopy, electron microscopy, confocal microscopy, TEM, 2 photon microscopy (inner ear as a strong preference, neuroscience, ophthalmology or peripheral nervous system as surrogates)
  • Strong record of publications relevant to histopathology, comparative anatomy, neuroscience in peer-reviewed academic journals
  • Demonstrated ability to assess, prioritize, resource and shepherd programs forward
  • Ability to function equally well in self-starter mode as well as a matrix-team
  • Outstanding interpersonal and communication skills

Knowledge, Skills, and Abilities:

      Preference will be given to candidates who additionally have

  • Demonstrated expertise with state of art histopathologic and imaging techniques
  • Facile vocabulary re inner ear imaging techniques, inner ear histopathology, cochlear function, neuroscience, ophthalmology or peripheral nervous system as surrogates
  • Detailed familiarity with inner ear anatomy and function

Scientist, Drug Discovery

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Nominated by Fierce Biotech in 2014 as a “Fierce 15” company “that could change how physicians approach infectious disease,” Seres Therapeutics is well­positioned to become the first company to bring drugs to patients comprised of carefully selected commensal bacteria. Seres is a dynamic biotechnology company in Cambridge, MA with a passion for developing new drugs in areas of high unmet need. Seres is well­financed and has an advanced program for treatment of recurrent Clostridium difficile infection and a second clinical­stage program for Inflammatory Bowel Disease. As part of growing its pipeline and expanding the therapeutic impact of this novel type of treatment, Seres plans to enter the clinic with new product candidates in a range of therapeutic areas in 2016 and beyond.

What’s in it for you?

In this role, you will build on Seres’ unique screening technologies to create novel Ecobiotics for new indications. You will develop new assays and implement cutting edge technologies to expand Seres’ capabilities to create and vet new combinations of commensal bacteria. We are creating live therapeutic products, and you will be at the center of that effort. You will be immersed in a learning organization, with a need to bring an open mind and an interest in rapidly developing and mastering the novel approaches required by new therapeutic space. You will develop important, enabling intellectual property and collaborate with functional teams including microbiology, bioinformatics and molecular biology.

How do you know if you’re the right fit?

If you are a scientist who enjoys learning and problem solving in a fast­paced, team­oriented environment and who has experience with implementing high­throughput screening technologies, you’ll fit in well at Seres. You will have previous experience performing screens for therapeutic candidates, including selecting high­throughput technologies and implementing them at the appropriate scale. You are comfortable with automation technologies, from robotics tools to liquid handlers and have developed medium­ to high­throughput screens. You are fearless at adapting existing tools to meet new needs. You are a hands­on scientist who enjoys working in an intense and collaborative environment. You’re motivated to succeed at developing new, innovative products. You will want to take the next steps in a new therapeutic area with a company that went from bench to bedside in record time.

The other stuff

This is typically a role best suited for PhD level candidates or exceptional non­PhD scientists with several years of experience. You will be comfortable working alone or in collaboration with Seres’ teammates, as required. You will be an experienced microbiologist, biochemist or chemist with a deep knowledge of lead screening. 

Lead Statistical Programmer

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Lead Statistical Programmer 

About Acceleron: 

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. 

Position Overview: 

The Lead Statistical Programmer will report to the Vice President of Biostatistics and work closely with the medical monitor, clinical operations lead, biostatistician, and data manager and execute independently on a variety of programming assignments for our development pipeline. 

Job Responsibilities:  

  • Develops and implements standard operating procedures for statistical programming function including best programming practices and quality control standards;
  • Designs and codes SAS programs for the relevant clinical programs with minimal guidance to ensure deliverables, for example clinical study report Table, Listing and Figures (TLFs), abstracts, posters, and manuscripts;
  • Learns and takes responsibilities for statistical deliverables such as SAP and ad-hoc statistical analysis;
  • Manages verbal and email requests for ad hoc data outputs and proactively works with the requestor for clarification as needed to generate the requested outputs;
  • Develops and maintains general-purpose and single-use SAS programs for the analysis and reporting of clinical data, including publication quality figures;
  • Develops global tools or product-wide utilities and macros that increase the efficiency and capacity of the statistical reporting;
  • Multi-tasks and manages multiple studies/programs and delivers on time and with quality;  and
  • Works with CRO programmers effectively; provides guidance and resolves programming issues on a timely basis. 

Minimum Qualifications: 

  • Master’s degree in statistics or biostatistics; plus
  • 4 years of experience as a statistical programmer or similar position in statistical programming in the Pharmaceutical or Biotech industry; 

AND 

  • Advanced understanding of statistical methodology applicable to clinical studies in drug development;
  • In depth knowledge and understanding of key SAS modules, including BASE SAS, SAS STATS, SAS GRAPH, SAS MACROS;
  • Experience with electronic data submissions in CDISC format, and proficiency with eCTD submission requirements, including define.xml; and
  • Knowledge of ICH/FDA/EMA Dataset, and TLF reporting requirements. 

Full-time; position is located at 128 Sidney Street, Cambridge, MA 02139. Please apply online at http://www.acceleronpharma.com/our-company/careers/ and reference job code 2015044; no phone calls please. 

*Recruiters - please do not send unsolicited resumes to this posting.

Manager, Marketing

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CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.    CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, saves time, and provides consistent quality.    The Company is currently experiencing significant growth in demand and seeks to bolster its commercial presence in the market by expanding our sales and marketing efforts. 

Reporting to CutisPharma’s VP, Sales & Marketing, the Manager, Sales/Marketing role is an exciting, dynamic position intended to encompass activities related to sales, marketing, and account management and provide a broad-based exposure across all key functions of CutisPharma’s commercial organization.  

Duties and Responsibilities:

  • Product sales-   personal promotion to pharmacists via trade show attendance and direct contact with customers

  • Assist Director, Trade Relations and Director, Managed Care in management of key customer accounts, including pharmacies/pharmacists, PBMs/Managed Care, Hospitals/GPOs, IDN’s wholesalers and distributors

  • Development of marketing materials used for Company promotional efforts, including journal advertising, trade shows, electronic media and product launches.

  • Flexibility to assist CutisPharma commercial team in other efforts, as required

Required Skills and Qualifications:

  • High energy, dynamic personality who works well in a team-based environment and interested in a role that encompasses marketing as well as direct customer sales
  • Pharmaceutical and/or other health-care related marketing/sales experience
  • Familiarity with pharmaceutical industry and pharmacy environment including pricing, contracting, flow of money, understanding of industry trends
  • Graphic design/layout experience-  familiarity with design software (e.g. Adobe Creative Suite)
  • Ability and interest to travel (~20% of time)

Education/Experience:

  • Bachelor’s degree required; preferably in field relevant to health-care related marketing; advanced degree (e.g. MBA, M.A., M.S., PharmD, or equivalent) preferred
  • Minimum of 5 years work experience in health care, pharmaceutical or medical device industry

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

  • Competitive compensation package as well as bonus incentives for excellent performance
  • Competitive medical, dental and vision insurance
  • Paid time-off program, Vacation
  • Tax-advantaged savings plans [401(k) with match and deferred savings plans]
  • Company-paid life insurance
  • Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

 

Senior Associate, Contract Management

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CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market. CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, saves time, and provides consistent quality. The Company is expanding our sales and marketing efforts into the GPO and Managed Care Markets. 

Reporting to CutisPharma’s Marketing Manager, the Sr. Associate Contract Management role is an exciting, dynamic position intended to maintain GPO and DoD contract pricing and customer contracts.

Duties and Responsibilities:

  • Execute Group Purchasing Organization and Federal Government related contract functions, including membership roster updates, contract pricing requests & administrative fee payments.

  • Produce monthly and quarterly contract reports showing relevant business trends, including contract status, growth, expirations, opportunities and issues.

  • Execute approved price file changes and contract amendments.

  • Maintenance of manufacturer customer eligibility lists.

  • Provide contract management support to Director, Trade Relations, Director, Managed Care, GPO and DoD  contacts, internal finance personnel, internal chargeback team and trade partners.

  • Communicating with GPO partners, and trade partners to obtain/define contract eligibility.

  • Completion of GPO member and trade partner audits and special reporting/projects as requested by specific GPO contract requirements.

 

.Required Skills and Qualifications:

  • 3 – 5 years pharmaceutical contract administration experience with GPO’s and FSS/DoD.
  • Experience with contract management systems a plus.
  • Strong computer & M/S Office skills. Develops spreadsheets models for moderately complex financial analyses.
  • Excellent verbal and written communication skills. Translates high volumes of data into meaningful information.

Education/Experience:

  • Bachelor’s degree.
  • Minimum of 3 - 5 years’ work experience in health care, pharmaceutical or medical device industry

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

  • Competitive compensation package as well as bonus incentives for excellent performance
  • Competitive medical, dental and vision insurance
  • Paid time-off program, Vacation
  • Tax-advantaged savings plans [401(k) with match and deferred savings plans]
  • Company-paid life insurance
  • Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

 

Payroll & Stock Plan Administrator

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This position is designed for a strong team contributor and leader to provide oversight, critical thinking, process evaluation and improvement to our company's payroll & stock plan administration. The role is a new position and will take on interesting and challenging responsibilities as our organization continues to grow in both size and complexity. This role will report to the Director of Accounting and will be a key part of the successful growth of the Finance department. Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

About the role:

  • Maintain employee/payroll records in Oracle HRIS & integrated ADP WorkForceNow systems including new hires and terminations, compensation changes, bank changes, tax changes, and other miscellaneous changes.

  • Process biweekly multi-state, exempt and non-exempt payroll using ADP WorkForceNow.

  • Responsible for overseeing Third Party Provider for International Payroll preparation.

  • Review new equity grants provided by Human Resources and prepare for upload into the stock option administration system Solium’s ShareWorks.

  • Communicate with participants regarding all stock plan related matters (new participant account setup, grants, and transaction processing, etc.)

  • Maintain participant demographic data (employee status, address changes, etc.) in Solium.

  • Assist in administering ESPP purchases, handle activity during open enrollment periods, and monitor and communicate contribution changes to Payroll at the beginning and during each offering.

  • Monitor restricted stock units vesting/release schedules and coordinate internally.

  • Coordinate with benefits and 401(k) providers to ensure accuracy of payroll records.

  • Perform daily, monthly, quarterly and yearly reconciliation of records between Stock Administration and General Ledger, HR, Payroll, transfer agent, etc.

  • Record all payroll-related journal entries in the GL.

  • Daily monitoring of Transfer Agent activity.

  • Review of 10b5-1 plans and daily transactions.

  • Lead implementation & maintenance of timesheet system.

  • Provide customer service to employees on payroll & equity related requests, including troubleshooting of HRIS self-service issues.

  • Assist with ad hoc projects as necessary and performs any other job duties as assigned.

About you:

  • Bachelor’s Degree

  • 5 Years of Experience with Payroll & Equity Administration

  • Ability to handle multiple tasks and react quickly in a fast-paced environment

  • Ability to effectively communicate and provide a high level of service to internal and external customers, including all levels within the company

  • Individual must be organized, detail-oriented, proactive and energetic

  • Experience with the following systems a plus: Oracle Fusion HRIS, ADP WorkForceNow, Solium’s ShareWorks, Concur

  • Ability to execute and follow-through to completion and documentation.

  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.

  • Independently motivated, detail oriented and good problem solving ability.

  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.

  • Excellent communication skills and ability to influence across multiple functions.

  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

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